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This randomized clinical trial is designed to compare three different rehabilitation methods for patients who have undergone anterior cruciate ligament (ACL) reconstruction. The study aims to determine whether low-load blood flow restriction training (LL-BFRt) is more effective than high-load eccentric training (HL-Et) and a sham LL-BFRt in improving three key areas: patellar position, muscle morphology, and leg function.
Study Design and Interventions
Participants will be randomly assigned to one of the three intervention groups. All groups will perform eccentric exercises, including single leg squats, single leg deadlifts, lateral step downs, and single leg calf raises. The key differences lie in the load and the use of blood flow restriction:
LL-BFRt Group: Participants will train at 30% of their repetition maximum (RM) while a cuff restricts blood flow to 70% of their artery occlusion pressure (AOP).
HL-Et Group: Participants will train at a higher intensity, using 70% of their repetition maximum (RM), with no blood flow restriction.
Sham LL-BFRt Group: Participants will perform the same exercises as the LL-BFRt group at 30% of their RM, but the cuff will not be inflated to a pressure that restricts blood flow.
After the training period, the researchers will compare the outcomes across all three groups to see which method leads to the most significant improvements in patella position, muscle morphology, and leg function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low load-BFRt | Experimental | 70% of the arterial occlusion pressure and 30% of the maximum repetition rate |
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| Sham Low load-BFRt | Sham Comparator | 10% of the arterial occlusion pressure and 30% of the maximum repetition rate |
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| High load-Eccentric training | Active Comparator | 70% of the maximum repetition rate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low load-BFRt | Procedure | The participants' two legs will be subjected to 70% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise. |
| Measure | Description | Time Frame |
|---|---|---|
| Patella position | Using a musculoskeletal ultrasonography, researchers will determine the patella position. | 8 weeks |
| Muscle cross-sectional area | Using a musculoskeletal ultrasonography, researchers will determine the cross-sectional area of vastus medial obliques muscle and hamstring muscles. | 8 weeks |
| Vastus medial obliques fiber angle | Using a musculoskeletal ultrasonography, researchers will determine the vastus medial obliques fiber angle. | 8 weeks |
| Quadriceps strength | Using a hand-held dynamometer, researchers will determine the isometric quadriceps muscle. | 8 weeks |
| Dynamic balance | Using a modified star excursion balance test, researchers will determine the distance of three positions of legs reaching, including forward, posteromedial, and posterolateral. | 8 weeks |
| Leg function | Using KOOS questionnaires will determine the subjective score of the patient's leg function. | 8 weeks |
| Anterior knee pain | Using the Kujala questionnaire will determine the subjective score of the patient's knee pain levels. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of anterior cruciate ligament reinjury | Researchers will determine the incidence of anterior cruciate ligament reinjury with the physical examination of Lachman's test. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| I Putu Gde Surya Adhitya | Contact | +6288975003567 | surya_adhitya@unud.ac.id |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical therapy laboratory, College of Medicine, Universitas Udayana and ROM Physiotherapy Private Clinic Denpasar | Denpasar | Bali | 80232 | Indonesia |
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| Sham Low load-BFRt | Procedure | The participants' two legs will be subjected to 10% arterial occlusion pressure when the physical therapist applies the BFR cuffs. After that, participants will be required to complete eccentric exercises with a maximum repetition count of 30%, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise. |
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| High load-Eccentric training | Procedure | The physical therapist will instruct the participants to complete eccentric exercises at a maximum of 70% repetitions, such as single leg squat, single leg deadlift, lateral step down, dan single leg calf raise. |
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